The best approach for QMS

Standard ISO 13485:2016 is a standard that covers a quality management system for a manufacturer of medical devices. According to the section 1 Scope, this standard is applicable even for your type of the product: In section 1 Scope of the ISO 13485:2016 is stated that this standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide a medical device and related service that meet customer requirements and applicable regulatory requirements.

For a company to be certified against ISO 13485, it needs to be in the medical device industry (manufacturer, distributor, importer). There are specific requirements that are connected with the specialty of medical devices like sterilization, installation and service activities, traceability of the medical device production, special requirements for traceability of implantable medical devices, validation of software is software is a medical device, and so on. 

The process of implementation is to create and document all of the processes required by the ISO 13485 standard, as well as customer and regulatory needs. Our ISO 13485:2016 toolkit combines documentation templates and checklists that demonstrate how to implement this standard through a step-by-step process. In addition, you can access help from our experts to keep you on the right path, ensuring a straight-forward journey to ISO 13485 certification. You can buy the whole toolkit, or you can buy separately documents that you considered that you need.

It is rather hard to estimate how much time you will need for the implementation process because it depends on many things like: number of the employees, do you have any experience before with quality management systems, how complicated your processes are, and so on. On average, we can say that for the company with 10 employees it will take 3-4 months, for the company with up to 50 employees, some 8-12 months. But, once again, this is just the estimation.

For more information about ISO 13485:2016 please see the following articles:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
• How to determine regulatory requirements according to ISO 13485:2016 https://advisera.com/13485academy/knowledgebase/how-to-determine-regulatory-requirements-according-to-iso-13485/
• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

You can see how our ISO 13485:2016 Documentation toolkit is composed here:

• ISO 13485:2016 Documentation Toolkit https://advisera.com/13485academy/iso-13485-documentation-toolkit/